Ann: FDA Grants PharmAust Pre-IND Meeting, page-27

Only official info I have seen in ASX releases is Q1 CY 2024.

However,

The Open Label extension study https://classic.clinicaltrials.gov/ct2/show/NCT06177431 , is expected to start 31st Jan.
My logic says our learned professors would want top line evidence completed before starting the extension study.
Acknowledging all 12 patients elected to remain on Monepantel, continue to be dosed on compassionate grounds, and all 12 are moving onto the extension study - there is a duty of care to these 12 patients (at a minimum) to process & understand the data available ASAP.

No doubt the meeting with the FDA will require as much completed & robust data/evidence as possible. Given FDA have promised a written response by the 13th Feb, the meeting must be "soonish" ... do we have a confirmation of the meeting date?

The phase 2/3 study to be commenced in Q2, 2024.

I would say February at the latest ....